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Clinical trial to test the efficacy and safety of topical application of IP in management of pain associated with muscles

A clinical trial to evaluate safety & efficacy of Polyherbal Pain Relief Ointment (Topical Application) in the Management of musculoskeletal pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/021874
Enrollment
100
Registered
2019-11-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

Interventions

Intervention1: Polyherbal Pain Relief Ointment: The Ointment is a combination of traditionally used aromatic oils with known as poly herbal pain-relieving effect such as joint and muscular sprain, bac

Sponsors

Vasu Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects of both genders with age >= 18 years. 2. Subjects who are willing to give written Informed Consent and willing to follow study procedures. 3. Subjects agreeing not to use any treatment for pain apart from the IP. 4. Subjects with documented diagnosis of moderate to severe pain with any of the condition, i.e., a. Sprains b. Shoulder and neck stiffness c. Backache d. Miscellaneous Musculo - skeletal pain not classified above 5. Acute back pain, acute neck pain, acute musculoskeletal pain with no underlying pathology 6. Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI). 7. All concurrent medications taken for any reason stable for 14 days.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
1. Change Visual Analog Scale (VAS) score at Baseline and on day 1, 2, 3 and 7. 2. Change in NPRS score at baseline and on Day 1, 2, 3 and 7. Timepoint: 7 days

Secondary

MeasureTime frame
1. Patient compliance questionnaire 2. Any AE or SAETimepoint: 7 Days

Countries

India

Contacts

Public ContactSubham Dutta

Vasu Healthcare Pvt. Ltd.

hsoni@vasuresearch.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026